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Job Description Summary
Responsible for assisting the GE Healthcare regulatory team in gaining approvals and maintaining the regulatory compliance of the business. The role will primarily be involved in, but not limited to, the collection, organization and submission of information related to medical devices reports, corrections and removals, and other mandatory requirements for medical devices, as well as providing general administrative support to the regulatory team to facilitate regulatory services to the business.
Job Description
Role Summary-
Responsible for assisting the GE Healthcare regulatory team in gaining approvals and maintaining the regulatory compliance of the business. The role will primarily be involved in, but not limited to, the collection, organization and submission of information related to medical devices reports, corrections and removals, and other mandatory requirements for medical devices, as well as providing general administrative support to the regulatory team to facilitate regulatory services to the business.
Responsibilities-
Prepare notarization copies of registration documents (DOC and RC)
Prepare and submit the dossier for receiving Radio Frequency Approval/Exemption letters from GKRCH.
Prepare and submit the dossier for receiving the license for shipment MRI to Russia
Prepare and submit the dossier for receiving the Notification for all products;
Ensure translation and notarization of Regulatory documents through translation agency.
Registration of Medical Devices for some CIS countries
Key Regulatory processes support and coordination:
customers in accordance with procedure
Handling requests from internal and external customers about registration certificates
Ensure payment of regulatory invoices in time
Carry out the process of documents storage
Administrative support
Qualifications-
• Current enrollment in BSc or Masters program (2025 - 2026 graduation years) in a medical devices field;
• Fluent English (upper-intermediate and higher) and Russian;
• Open-minded, fast learner, eager for professional development;
• Structural, good executor, experienced PC user (Excel, Word, Power Point, Adobe);
• Active life position;
• Excellent communication skills;
• Skills of planning and self-organization
• Eligible to work in Russia
Additional Information
Relocation Assistance Provided: No